Profile and outcome of cancer patients enrolled in contemporary phase I trials.

Autor: Alouani E; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France; Digestive Medical Oncology Department, IUCT-Rangueil, Toulouse Hospital University, Toulouse, France. Electronic address: alouani.e@chu-toulouse.fr., Gazzah A; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: anas.gazzah@gustaveroussy.fr., Mercier S; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: sandrine.mercier@gustaveroussy.fr., Bahleda R; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: ratislav.bahleda@gustaveroussy.fr., Hollebecque A; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: antoine.hollebecque@gustaveroussy.fr., Michot JM; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: jean-marie.michot@gustaveroussy.fr., Baldini C; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: capucine.baldini@gustaveroussy.fr., Ammari S; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: samy.ammari@gustaveroussy.fr., Champiat S; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: stephane.champiat@gustaveroussy.fr., Marabelle A; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: aurelien.marabelle@gustaveroussy.fr., Postel-Vinay S; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: sophie.postel-vinay@gustaveroussy.fr., Ribrag V; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: vincent.ribrag@gustaveroussy.fr., Loriot Y; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: yohann.loriot@gustaveroussy.fr., Aix SP; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: santiago.ponce@gustaveroussy.fr., Mahjoubi L; Drug Development Department (DITEP), Gustave Roussy Cancer Campus, Villejuif, France. Electronic address: linda.mahjoubi@gustaveroussy.fr.
Jazyk: angličtina
Zdroj: European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2023 Jul; Vol. 188, pp. 1-7. Date of Electronic Publication: 2023 Apr 20.
DOI: 10.1016/j.ejca.2023.04.006
Abstrakt: Background: Phase I trials historically involved heavily pretreated patients (pts) with no more effective therapeutic options available and with poor expected outcomes. There are scare data regarding profile and outcomes of pts enrolled into modern phase I trials. Here, we sought to provide an overview of pts' profile and outcome into phase I trials at Gustave Roussy (GR).
Methods: This is a monocentric retrospective study, including all pts enrolled into phase I trials at GR from 2017 to 2021. Data regarding pts' demographics, tumour types, investigational treatments and survival outcomes were collected.
Results: In total, 9482 pts were referred for early phase trials; 2478 pts were screened, among which 449 (18.1%) failed screening; 1693 pts finally received at least one treatment dose as part of a phase I trial. Median age of pts was 59 years old (range, 18-88) and most common tumour types included gastrointestinal (25.3%), haematological (15%), lung (13.6%), genitourinary (10.5%) and gynaecologic cancers (9.4%). Amongst all pts treated and evaluable for response (1634 pts), objective response rate was 15.9% and disease control rate was 45.4%. Median progression-free survival and overall survival were, respectively, 2.6 months (95% confidence interval [95% CI], 2.3; 2.8) and 12.4 months (95% CI, 11.7; 13.6).
Conclusion: As compared with historical data, our study shows that outcomes of pts included into modern phase I trials have improved and that these trials constitute nowadays a valid and safe therapeutic option. These updated data provide facts for adapting the methodology, role and place of phase I trials over the next years.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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